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Monitoring Cellular Immunity After Kidney and Liver Transplantation

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ClinicalTrials.gov Identifier: NCT00683748
Recruitment Status : Unknown
Verified February 2009 by Karolinska University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 23, 2008
Last Update Posted : February 5, 2009
Sponsor:
Collaborator:
Uppsala University Hospital
Information provided by:
Karolinska University Hospital

Brief Summary:
After transplantation, if insufficient immunosuppression is achieved, rejection and graft loss follows. If to much immunosuppression is given, the patient suffers risk for infections and malignancies. Despite careful dosing and monitoring of drug levels, the biological effects of the immunosuppression given is difficult to predict and varies significantly. As a result, the degree of immunosuppression (or immunosuppressive status) remains unknown and clinical problems related to under- or over-immunosuppression are common. Thus, a method to determine the degree of immunosuppression would be of great and direct clinical importance and the results would be improved. T cells are the principal cells of the immunesystem causing rejection. Furthermore, all immunosuppressive regimes targets T cells. Thus, T cell reactivity could reflect the biological effects of the immunosuppression and the immunosuppressive status. In addition, T cells are of crucial importance in the immunedefence against viral diseases. Therefore, data on virus specific T cell reactivity could aid in diagnosis, monitoring and treatment of viral disease. The proposed study aim to develop a clinically useful method to monitor cellular immunity and the degree of immunosuppression after transplantation by determinations of the specific T cell reactivity to several clinically relevant viruses.

Condition or disease
Terminal Kidney Failure Terminal Liver Failure

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Monitoring Cellular Immunity After Kidney and Liver Transplantation
Study Start Date : March 2007
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Group/Cohort
Kidney transplant
Liver transplant



Primary Outcome Measures :
  1. T cell reactivity to viral antigens [ Time Frame: Pre-transplantation and 2 weeks, 1, 3, 6 and 12 months after transplantation ]

Biospecimen Retention:   Samples Without DNA
Serum, whole blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing kidney or liver transplantation at the Karolinska University Hospital
Criteria

Inclusion Criteria:

  • All patients undergoing kidney or liver transplantation at the Karolinska University Hospital

Exclusion Criteria:

  • Abscence of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683748


Locations
Sweden
Lars Wennberg
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Uppsala University Hospital
Investigators
Principal Investigator: Lars Wennberg, MD, PhD Karolinska University Hospital
Study Director: Gunnar Tyden, MD, PhD Karolinska University Hospital

Responsible Party: Lars Wennberg, Associate Professor, Karolinska University Hospital, Department of Transplantation Surgery
ClinicalTrials.gov Identifier: NCT00683748     History of Changes
Other Study ID Numbers: T cell study
First Posted: May 23, 2008    Key Record Dates
Last Update Posted: February 5, 2009
Last Verified: February 2009

Keywords provided by Karolinska University Hospital:
Transplantation
Immunological monitoring
Immunological risk
T cell reactivity
Cellular immunity

Additional relevant MeSH terms:
Renal Insufficiency
Liver Failure
Kidney Diseases
Urologic Diseases
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases